Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels with Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Keratitis Resisting Healing Medical Treatment

TBF Genie Tissulaire1 site in 1 country5 target enrollmentJune 29, 2020

ConditionsKeratitis

InterventionsLV-Visio-AMTRIX

DrugsLV-Visio-AMTRIX

Overview

Phase: Phase 2
Intervention: LV-Visio-AMTRIX
Conditions: Keratitis
Sponsor: TBF Genie Tissulaire
Enrollment: 5
Locations: 1
Primary Endpoint: Keratitis healing within 15 days after the beginning of the treatment
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this open, mono center trial is to assess the impact of the use of an amniotic membrane on the healing of a keratitis resistant to medical treatment.

Registry

clinicaltrials.gov

Start Date

June 29, 2020

End Date

January 7, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

TBF Genie Tissulaire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female; age between 18 and 65 years.
•Patient with non-infectious keratitis resistant to medical treatment for more than 15 days or recurrent after healing treatment.
•Patient with quantitative and qualitative score for inflammatory ocular signs \>
•Patient with Oxford grade \>
•Informed and consenting patient with a relative or friend available to instill eye drops if necessary.
•Patient affiliated to a social security system or beneficiary of such a system.

Exclusion Criteria

•Patient with active infectious keratitis (bacterial, parasitic or viral).
•Patient with allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein.
•Current contact lens wear, including scleral lenses.
•NSAID eye drops and any drops containing preservatives.
•Antibiotic, anti-viral, anti-parasitic eye drops.
•Patient with identified causes for the keratitis for which discontinuation of medical treatment beneficial.
•Ocular surgery in the 3 months preceding the inclusion in the study.
•Monophtalmic patient.
•Person deprived of liberty by a judicial or administrative decision.
•Adult subjected to a legal protection measure or unable to express his/her consent.

Arms & Interventions

LV-Visio-AMTRIX

Sutureless amniotic membrane supported by a biological ring.

Intervention: LV-Visio-AMTRIX

Outcomes

Primary Outcomes

Keratitis healing within 15 days after the beginning of the treatment

Time Frame: 15 days

Keratitis observed under slit lamp using fluorescein instillation. Keratitis considered healed if epithelialization of more than 50% and/or Oxford \< grade 2

Secondary Outcomes

Change in eye dryness(15 days, 30 days, 45 days)
Stabilisation or decrease of pain evaluated on visual analog scale(1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days)
Preservation of epithelialization(15 days, 30 days, 45 days)
Stable or decreased score for inflammatory and clinical signs of the ocular surface(1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days)